Pain Patch Recalls

Unsafe Drugs

The Pain Patch: Plagued by Problems

On February 12, 2008, Johnson & Johnson pain patches containing the prescription painkiller fentanyl and sold under the brand name Duragesic patch were recalled because of a flaw that could cause patients to overdose.

The Duragesic patch is a thin, adhesive, rectangular patch that is worn on your skin and delivers fentanyl, a strong narcotic pain-relieving medicine delivered through the skin into the bloodstream. Duragesic patch is a prescription product used by people who suffer from constant moderate to severe chronic pain needing to be treated 24/7 and cannot be treated by a combination of narcotic, short-acting, or non-narcotic pain treatment products.

On March 1, 2008, Actavis Inc., the U.S. manufacturing and marketing division of the international generic pharmaceutical company Actavis Group hf, announced that its subsidiary Actavis South Atlantic LLC is proceeding with the voluntarily recall from wholesalers and pharmacies of all lots of Fentanyl transdermal system CII patches.

Do you have a pain patch recall lawsuit?

This recall is an expansion of the initial recall of 14 lots of Fentanyl transdermal patches announced in February 2008. That recall was due to the identification of a possible fold-over defect present in the product that potentially could cause fentanyl gel leakage.

The recalled pain patches all have expiration dates on or before December 2009 and are manufactured by ALZA Corporation, an affiliate of PriCara.

There may be a cut in the lining of the reservoir of some of the pain patches causing the gel to leak. Direct contact with the powerful opiate may cause an overdose for the patient or caregiver; an overdose could cause death.

Duragesic patch side effects may cause hives, difficulty breathing, and swelling of your face, lips, tongue, or throat; these would be considered life threatening side effects. Serious side effects include weakness, shallow breathing, fainting, clammy skin, and bruising.

Another way to overdose from Duragesic pain patches is exposure to direct heat sources such as heating pads or electric blankets, heat lamps, saunas, hot tubs, and heated water beds that could increase the amount of narcotic fentanyl gel that gets absorbs by the skin.

In July 2005 the FDA issued a safety advisory emphasizing the safe use of the fentanyl pain patch known by the brand name Duragesic and other generic pain patches. Two and one-half years later in December 2007 the FDA issued another fentanyl safety advisory. Despite this advisory, a large number serious problems and deaths continue to happen.

Doctors have also wrongly prescribed the fentanyl patch to patients for acute pain following surgery, for headaches, occasional or mild pain for which a fentanyl patch should never be prescribed.

Do you have a pain patch injury lawsuit? If you live in PA, NJ, or WV, contact of counsel law firm of Anapol Schwartz.